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Completed

NCT Number: NCT05504551

Effect of Superficial Cervical Plexus Block on Post Operative Nausea and Vomiting in Tympanomastoid Operations

post operative nausea and vomiting are very common after tympanomastoid operations, in this study we are investigating the effect of superficial cervical plexus block on the incidence and severity of those post operative complications.

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Key information

Conditions

Postoperative Nausea and Vomiting Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty Of Medicine- Cairo Univesity

Cairo, 12521, Egypt

About this study

various treatments and regimens have been tried to overcome the problem of postoperative nausea and vomiting after tympanomastoid surgery. superficial cervical plexus block seems so promising in this regards as it may reduce the incidence and severity of PONV through 3 mechanisms: primarily through blocking vagal afferents to the middle ear which mediate the vomiting reflex, and secondarily through decreasing pain which aggravates PONV, and finally through decreasing intra and post operative opioid consumption due to adequate analgesia which in turn avoids opioids side effects including PONV.

the study group will receive superficial cervical plexus block while the control will receive the same block while given placebo instead of (lidocain/bupivacaine mixture) incidence and severity of PONV will be recoded according to a scale to find the difference between both groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients belonging to American Society of Anesthesiologists physical status I-II.
  • operation time less than 4 hours.

Exclusion criteria

  • • American Society of Anesthesiology (ASA) physical status ≥ III.
  • Uncooperative or mentally retarded patients.
  • Known Allergy or hypersensitivity to lidocaine or bupivacaine.
  • Patients known to have gastritis or Gastro-oesophageal reflux disease (GERD).
  • History of PONV or motion sickness.
  • Operation duration (short less than 30 minutes or prolonged more than 240 min).
  • Patients with chronic renal disease (serum creatinine level ≥2.0mg/dl) or on renal replacement therapy (dialysis).
  • Patients with chronic cholecystitis (history of recurrent or persistent vomiting)
  • Skin inflammation and cellulitis.

Treatment and study plan

ultrasound guided superficial cervical plexus block

Procedure

SCP block is given using high frequency linear ultrasound probe connected to an ultrasound machine to visualize SCP posterior to the midpoint of SCM muscle. Once SCP is identified, a combination of 5 ml bupivacaine (0.5%) and 5 ml lidocaine (2%) are injected after negative aspiration followed by injection of 1 ml to confirm the area, using a 22 gauge B-bevel needle Echogenic Needle.

Primary outcomes

  1. PONV incidence over 24hour postoperative

    Time frame: 24 hours

    incidence of PONV according to PONV score from 0 to 3 where: 0= No nausea,no vomiting, 1= Nausea present, no vomiting, 2= Nausea present, vomiting present, 3= Vomiting>2 episodes in 30 minutes, i.e., number of patients with PONV score of 0, number of patients with PONV score of 1, number of patients with PONV score of 2 and number of patients with PONV score of 3.

Secondary outcomes

  1. post operative pain score measured by visual analogue score (VAS) from 0 to 10, where 0= no pain and 10= unbearable pain.

    Time frame: up to 24 hours postoperative

    post operative pain is assessed by visual analogue score from 0 to 10. patients are educated that 0= no pain, 5= distressing pain, 10= unbearable pain.

  2. Intraoperative and postoperative complications

    Time frame: 24 hours

    Complications in the form of bleeding and facial nerve palsy

  3. To monitor intraoperative hemodynamics

    Time frame: up to 4 hours

    To monitor intraoperative heart rate and blood pressure

  4. Side effects and toxicity of drugs

    Time frame: 24 hours

    record any side effects (local anaesthetic lidocaine-bupivacaine) e.g allergy, convulsions, hypotension.

  5. Need for postoperative analgesia

    Time frame: 24 hours

    first analgesic request

  6. To detect complications of regional ear block

    Time frame: 24 hours

    record complications include (hematoma-facial nerve palsy-oedema)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Superficial Cervical Plexus Block on Incidence and Severity of Post Operative Nausea and Vomiting in Tympanomastoid Operations in Adults, Randomized Controlled Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 17, 2022
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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